| Dr. pen Microneedling System (K230420) | Guangzhou Ekai Electronic Technology Co., Ltd. | 2023-08-11 |
| NOxBOXi Nitric Oxide Delivery System (K231823) | Linde Gas & Equipment, Inc. | 2023-08-11 |
| Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile (K231408) | Shandong Intco Medical Products Co, Ltd. | 2023-08-11 |
| Electronic Blood Pressure Monitor (K230642) | Dongguan Kangweile Electronic Technology Co., Ltd. | 2023-08-11 |
| Powder Free White, Black, and Purple Nitrile Examination Glove (K231439) | S&S Glove Corporation | 2023-08-11 |
| Erchonia FX-405 (K231409) | Erchonia Corporation | 2023-08-11 |
| Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ (K230626) | Ge Medical Systems Information Technologies, Inc. | 2023-08-11 |
| BlueStar CGM insulin dose calculator (K222888) | Welldoc, Inc. | 2023-08-11 |
| Otsuka Digital Feedback Device-RW (K223463) | Otsuka America Pharmaceutical, Inc. | 2023-08-11 |
| ZenPro 40 (K230268) | BLUECORE COMPANY Co., Ltd. | 2023-08-10 |
| EnSite™ X EP System (K231415) | ABBOTT MEDICAL | 2023-08-10 |
| Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 (K230428) | Ambu A/S | 2023-08-10 |
| ArtiFascia (K223445) | Nurami Medical , Ltd. | 2023-08-10 |
| ID NOW COVID-19 2.0 (K221925) | Abbott Diagnostics Scarborough, Inc. | 2023-08-10 |
| GEM Premier 7000 with IQM3 (K223608) | Instrumentation Laboratory Company | 2023-08-10 |
| Accu-Chek Guide Solo diabetes manager blood glucose monitoring system (K213131) | Roche Diabetes Care GmbH | 2023-08-10 |
| AirLife DuoTherm™ Humidification System (K231380) | Vyaire Medical, Inc. | 2023-08-10 |
| HAVAb IgG II (K222850) | Abbott Laboratories | 2023-08-10 |
| Accu-Chek Solo micropump system with interoperable technology (K213134) | Roche Diabetes Care GmbH | 2023-08-10 |
| SuperBall Meniscal Repair System (K223500) | Arcuro Medical , Ltd. | 2023-08-10 |
| ANNE One (K223711) | Sibel Health, Inc. | 2023-08-10 |
| ReliOn Premier BLU Blood Glucose Monitoring System (K230625) | I-Sens, Inc. | 2023-08-10 |
| Aura 10 PET/CT (K231420) | Xeos Medical | 2023-08-10 |
| Conductive Silicone Rubber Electrode (K231167) | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 |
| Intense Pulsed Light System (K231394) | Smedtrum Medical Technology Co., Ltd. | 2023-08-09 |
| Medline UNITE® REFLEX® Nitinol Staple System (K231885) | Medline Industries, LP | 2023-08-09 |
| Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) (K231376) | Smith & Nephew, Inc. | 2023-08-09 |
| Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System (K231114) | Zimmer Switzerland Manufacturing GmbH | 2023-08-09 |
| Conductive carbon film electrode (K231164) | Guangzhou Xinbo Electronic Co., Ltd. | 2023-08-09 |
| Polyisoprene Surgical Gloves (K230304) | Puyang Linshi Medical Supplies Co., Ltd. | 2023-08-09 |
| Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K232039) | Grand Work Plastic Products Co., Ltd. | 2023-08-09 |
| VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack (K231525) | Ortho Clinical Diagnostics | 2023-08-09 |
| Air Smart Extra Spirometer (K222443) | Feellife Health, Inc. | 2023-08-09 |
| Ceribell Instant EEG Headband (K232052) | Ceribell, Inc. | 2023-08-08 |
| Efai Pacs Picture Archiving and Communication System Pro (K232100) | Ever Fortune.Ai, Co., Ltd. | 2023-08-08 |
| Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (K222439) | Siemens Healthcare Diagnostics, Inc. | 2023-08-08 |
| Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (K230620) | Gentuity, LLC | 2023-08-08 |
| Protective Gown AAMI Level 4 (K222128) | Kenpax International Limited | 2023-08-08 |
| LW Implant System (K223924) | Ossvis Co., Ltd. | 2023-08-08 |
| Rubicon™ Control Support Catheter (H749394323506A1) (K223633) | Boston Scientific Corporation | 2023-08-08 |
| Visual-ICE Cryoablation System (K230551) | Boston Scientific Corporation | 2023-08-08 |
| Arthrex TightRope II (K231857) | Arthrex, Inc. | 2023-08-08 |
| Disposable Medical Examination Nitrile Gloves (K232008) | Raxwell Industrial, LLC | 2023-08-08 |
| Reprocessed Agilis NxT Steerable Introducer (K230376) | Innovative Health, LLC | 2023-08-07 |
| Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator (K231490) | STERIS Corporation | 2023-08-07 |
| V-PRO maX 2 Low Temperature Sterilization System (K223476) | STERIS Corporation | 2023-08-07 |
| Vis-U-All Low Temperature Sterilization Pouches (K231500) | STERIS Corporation | 2023-08-07 |
| Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (K223713) | Better Care Plastic Technology Co., Ltd. | 2023-08-07 |
| LineSider® Spinal System (K231098) | Integrity Implants, Inc. | 2023-08-07 |
| PRO-LITE Sterilization Tray (K231501) | STERIS Corporation | 2023-08-07 |
| SQA-iO Sperm Quality Analyzer (K220828) | Medical Electronic Systems , Ltd. | 2023-08-07 |
| Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape (K231488) | Steris | 2023-08-07 |
| Stryker Resorbable Fixation System (K230733) | Stryker Leibinger GmbH & Co KG | 2023-08-05 |
| Alinity h-series System (K220031) | Abbott Laboratories | 2023-08-04 |
| Bladeless Trocar – Artemis Lap Cannula (K231400) | T.A.G. Medical Products Corporation, Ltd. | 2023-08-04 |
| Titus Titanium Cervical by SAGICO (K221138) | Sagico VA USA, LLC | 2023-08-04 |
| ECGenius System (K223787) | Cath Vision Aps | 2023-08-04 |
| HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) (K232005) | Smith & Nephew, Inc. | 2023-08-04 |
| iTEMPSHIELD (K232010) | Aion Biosystems, Inc. | 2023-08-04 |
| Dewin Blastocyst Medium (with HSA and without HSA) (K231370) | Donnevie Medical Technology (Shanghai) Co. , Ltd. | 2023-08-04 |
| Annabella Breast Pump (K230672) | Annabella , Ltd. | 2023-08-04 |
| T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button (K231404) | Healthium Medtech Limited | 2023-08-04 |
| LEGACY® IPC (K232006) | Ig Technology, Ltd. | 2023-08-04 |
| Dentis s-Clean Regular Abutment (K230126) | Dentis Co., Ltd. | 2023-08-04 |
| Citric Complete Liquid Citric Acid Concentrate (K223431) | Nipro Renal Solutions USA, Corp. | 2023-08-04 |
| STRETTO™ Cable System (K231333) | Globus Medical, Inc. | 2023-08-04 |
| Premier Resolution System (K222635) | Trinity Biotech (Primus Corporation, Dba Trinity Biotech) | 2023-08-04 |
| CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) (K223507) | Good Doctors Co., Ltd. | 2023-08-04 |
| Surgeon Controlled Arm (K223673) | Levita Magnetics International Corp | 2023-08-04 |
| Extremity Staple (K231458) | Restor3D | 2023-08-03 |
| TubaVent Balloon Dilatation System (K223542) | Spiggle & Theis Medizintechnik GmbH | 2023-08-03 |
| ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) (K232015) | Atmos Medizintechnik GmbH & Co. KG | 2023-08-03 |
| Viz HCM (DEN230003) | Viz. Ai, Inc. | 2023-08-03 |
| Sterile Water for Inhalation in 1L Flexoval ® bottles. (K223551) | Hometa, Inc. | 2023-08-03 |
| VisiRad XR (K223133) | Imidex, Inc. | 2023-08-03 |
| Sequel Tampon with Plastic Applicator (K230419) | Tampro, Inc. | 2023-08-03 |
| Surgical Face Masks, Model: EFMDS-L50Pn BLU (K230380) | Iris USA | 2023-08-03 |
| LifeSPARC System (K232132) | Cardiacassist, Inc. | 2023-08-03 |
| Medical Diode Laser, Model S1Pro (K231548) | Wuhan Pioon Technology Co., Ltd. | 2023-08-03 |
| TiLink-L Joint Fusion System (K231831) | Surgentec | 2023-08-03 |
| MENIX®; MENIX® DUO (K223122) | S.B.M. Sas (Science & Bio Materials) | 2023-08-03 |
| NorthStar OCT System (K231654) | Seaspine, Inc. | 2023-08-03 |
| YosemiteView 4343W/YosemiteView 3643W (K232058) | Careray Digital Medical Technology Co., Ltd. | 2023-08-03 |
| Lumbar Expandable lnterbody Spacers -Additional Indications/Implants (K221894) | Globus Medical, Inc. | 2023-08-03 |
| Eblator Device (K231126) | E Surgical, LLC | 2023-08-02 |
| Disposable Ureteral Access Sheath (K230748) | Youcare Technology Co.,Ltd. (Wuhan) | 2023-08-02 |
| ActivSight Intraoperative Imaging System (K231344) | Activ Surgical, Inc. | 2023-08-02 |
| BPBIO750 (K231174) | Inbody Co., Ltd. | 2023-08-02 |
| Disposable Needle Guides and Grids (K223689) | Advance Medical Designs, Inc. | 2023-08-02 |
| SKEEPER (K230613) | Smartsound Corporation | 2023-08-02 |
| Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine (K223553) | Brainlab AG | 2023-08-02 |
| Ingenia Elition R5.7.1 SP4 MR Systems (K232030) | Philips Medical Systems Nederland B.V. | 2023-08-02 |
| Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors (K223114) | Gm Dos Reis Industria E Comerico Ltda. | 2023-08-02 |
| Mineral Collagen Composite Bioactive Extra Moldable (K231942) | Collagen Matrix, Inc. | 2023-08-02 |
| Chemfort® Catheter Adaptor (K231286) | Simplivia Healthcare , Ltd. | 2023-08-02 |
| Self-Cath Closed System (K223821) | Coloplast | 2023-08-02 |
| Sapphire X3 Anterior Cervical Plate System (K231593) | Spinal Elements, Inc. | 2023-08-02 |
| Immunoglobulin G (IgG) (K221114) | Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | 2023-08-02 |
| REAL INTELLIGENCE™ CORI™ (K231963) | Blue Belt Technologies, Inc. | 2023-08-01 |
| uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis (K230162) | Shanghai United Imaging Healthcare Co., Ltd. | 2023-08-01 |